An interventional study of Endoluminal treament of thoracic lesions in Thoracic Aortic Aneurysms, Thoracic Transections and Intramural Hematoma, sponsored by Rodney A. White, M.D.. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-09-14.
Sponsored by Rodney A. White, M.D. · Not applicable, Interventional, and Treatment
The primary objective of this trial is to determine whether the Talent Thoracic Stent Graft, an investigational device, is a safe and effective method of treating thoracic aortic aneurysms (abnormal ballooning of the vessel wall) and other thoracic lesions (dissections, transections, pseudoaneurysms, penetrating ulcers, etc.). The endovascular method is a substitute for the major operation that is performed to treat the lesions.
The endovascular method consists of the insertion of catheters (vinyl tubes) into both groin arteries. These catheters then allow positioning of artificial tubes or stent graft(s) into the diseased blood vessel without the need for major surgery which involves opening the chest. The blood vessel problem (thoracic aortic aneurysm/lesion) will be treated using an artificial bypass tube (stent graft) that will be placed inside the diseased artery. The stent graft(s) that will be used are made of polyester graft fabric sewn to a self-expanding nickel-titanium (Nitinol) wire frame and is manufactured by Medtronic AVE, Santa Rosa California.
Aneurysms/lesions can be located in any position along the length of the aorta. This study evaluates only aneurysms/lesions that occur in the descending part of the thoracic aorta as it traverses the chest and enters the abdominal cavity. The risk of thoracic aneurysms/lesions is that they rupture without warning. The risk of rupture increases as the aneurysm size increases. Following rupture, almost all patients expire within the first 24 hours. For this reason treatment of thoracic aneurysms/lesions is recommended by conventional surgical means if the patient is a candidate for an operation. The conventional operation involves occluding the aorta and replacing the aneurysm with a cloth tube that is sewn to replace the diseased part of the aorta. The major surgery and occlusion of the aorta that is part of the conventional surgery is directly related to several complications that have been reported in the literature. In addition, many patients are too ill for conventional surgery due to concomitant illnesses.
After the procedure, the patient will be followed at regular intervals (pre-discharge, 1 month, 6 months, 12 months and every year thereafter for life) as part of the evaluation of the experimental treatment. During this time, the patient will have several tests performed to evaluate the function of the repair. The tests will include clinical examination, x-rays of the chest and spiral CT scan. The experimental part is the placement of the TALENT Stent-Graft System using the catheter (endovascular) methods. The risk of the experimental catheter bypasses is that the procedure may not be successful. In most cases, this would require a standard operation to repair the problem. Sometimes there are other risks such as injury to the vessels. Small pieces of diseased arteries may be dislodged which may require removal. Bleeding may occur from introduction sites, and rarely, infection may develop. If a catheter bypass is unsuccessful, there can be added discomfort because the procedure may last longer.
The benefits of the procedure are that the patient might avoid some of of the pain and discomfort associated with standard operations. Major surgery is avoided and hospital stay may be much shorter. Patients may be able to return to usual daily activities sooner. In addition, patients who are too high risk for conventional surgical treatment can have their aneurysm treated using the endovascular graft if their anatomy is appropriate
131 studies on the registry are indexed under Aortic Aneurysm, Thoracic; 33 are open to participants now.
This study's enrollment of 304 is above the median of 50 across 62 interventional studies indexed under Aortic Aneurysm, Thoracic.
Browse Aortic Aneurysm, Thoracic studies →Rodney A. White, M.D. is the lead sponsor of 2 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Subjects who participate in this study as study patients must fulfill the following criteria:
Subject is diagnosed with one of the following conditions of the descending thoracic aorta. All conditions must be verified by diagnostic imaging [ultrasonography, computed tomography (CT), magnetic resonance imaging (MRI) or angiography].
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Endoluminal treatment of thoracic lesions
Device: Endoluminal treament of thoracic lesions
Endoluminal treament of thoracic lesions with a thoracic stent-graft
Number of Participants With Successful Endoluminal Treatment of Thoracic Lesion
Evaluate the number of patients who had successful treatment of their thoracic lesion using the Medtronic Talent Endoluminal Stent Graft..
Time frame: Throughout study completion, an average of 1 year
Number of Participants With Successful Device Delivery and Deployment
Evaluate the number of patients where the thoracic device was successfully delivered and deployed within the patients' thoracic lesion.
Time frame: Throughout study completion, an average of 1 year
Participants were recruited over several years from patients in the hospital and referrals from other hospitals, providers and clinics in the area.
| Milestone | Endoluminal Treatment of Thoracic Lesions |
|---|---|
| Started | 304 |
| Completed | 304 |
| Not completed | 0 |
Evaluate the number of patients who had successful treatment of their thoracic lesion using the Medtronic Talent Endoluminal Stent Graft..
| Participants | Participants Whose Thoracic Lesions Were Successfully Excluded and Treated |
|---|---|
| Number of Participants With Successful Endoluminal Treatment of Thoracic Lesion | 294 |
Evaluate the number of patients where the thoracic device was successfully delivered and deployed within the patients' thoracic lesion.
| Participants | Number of Participants With Successful Endoluminal Device Delivery and Deployment |
|---|---|
| Number of Participants With Successful Device Delivery and Deployment | 269 |
Collected over From treatment through 5 years. Non-serious events are listed at a 1% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Exclusion of Thoracic Lesions | 86/304 (28.3%) | 107/304 (35.2%) | 4/304 (1.3%) |
| Event | Exclusion of Thoracic Lesions |
|---|---|
| EndoleakVascular disorders | 107/304 |
| MICardiac disorders | 14/304 |
| StrokeGeneral disorders | 14/304 |
| Acute renal failureRenal and urinary disorders | 9/304 |
| InfectionSurgical and medical procedures | 8/304 |
| Aortic DissectionVascular disorders | 7/304 |
| Respiratory distressRespiratory, thoracic and mediastinal disorders | 7/304 |
| Transient paralysisGeneral disorders | 5/304 |
| Event | Exclusion of Thoracic Lesions |
|---|---|
| HematomaSurgical and medical procedures | 4/304 |
Number of participants treated
| Age, Categorical(Participants) | Number of Patients |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 304 |
| >=65 years | 0 |
| Sex: Female, Male(Participants) | Number of Patients |
|---|---|
| Female | 92 |
| Male | 212 |
| Ethnicity (NIH/OMB)(Participants) | Number of Patients |
|---|---|
| Hispanic or Latino | 125 |
| Not Hispanic or Latino | 179 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | Number of Patients |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 30 |
| Native Hawaiian or Other Pacific Islander | 5 |
| Black or African American | 70 |
| White | 199 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(Participants) | Number of Patients |
|---|---|
| United States | 304 |
Plan to share: No
The record gives a start of May 2002, a primary completion of Jan 2021 and a completion of Jan 2021. It does not say whether these dates are actual or estimated.
Results were first posted in Sep 2023, 2 years 8 months after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jun 2023. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Rodney A. White, M.D.